Until now, New Jersey public employees have been at a disadvantage compared with those insured by private employers when seeking to use a medication for a treatment that hasn’t been approved by the U.S. Food and Drug Administration.
A bill advancing in the Legislature would change that by requiring the state and school health plans to cover these “off-label” prescriptions, which are particularly important for cancer treatments.
Assemblyman Herb Conaway Jr., a primary-care doctor, is the sponsor of the bill.
A key advocate for the bill has been the American Cancer Society’s Cancer Action Network. Ethan Hasbrouck, the network's advocacy director, said doctors frequently try different combinations of drugs, outpacing the FDA’s ability to approve these uses.
“Some drugs are found to work against many different types of tumors,” Hasbrouck said, adding “drug combinations tend to change over time” as doctors try to determine which ones work best.
Drugs go through clinical trials before the FDA determines whether they work and are safe. However, this process can take years, and sometimes older, generic drugs are found to be safe for new uses. It’s legal for any drugs other than opioids to be prescribed for off-label uses, but pharmaceutical companies can’t market the drugs for that purpose. A 2008 study of cancer doctors found that eight in 10 had used drugs off-label.
An example of a common off-label drug cited by the American Cancer Society is the use of the antianxiety drug lorazepam, which is sold as Ativan, to control nausea during cancer treatments.
The roughly 800,000 residents in the State Health Benefits Program and School Employees’ Health Benefits Program weren’t covered under the existing state requirement that insurance plans cover these off-label uses. That’s because the current requirement only applies to those who have insurance through private-sector jobs.
That puts patients who are public workers in a position in which their insurance carriers could simply deny payment for these uses, Hasbrouck said.
While the state’s insurers frequently are opposed to expanded benefits, the industry didn’t unite in opposition to the bill. New Jersey Association of Health Plans President Wardell Sanders said insurers would agree to treat public employees the same as private-sector workers.
But Sanders raised an objection to a provision of the current standards that govern which off-label uses must be approved. Currently, drugs must be approved for off-label use if one peer-reviewed journal article found them to be effective.
Sanders noted that other states generally require a larger number of published studies before requiring insurers to cover off-label uses.
“We would urge that that be tightened up in the existing law as you move forward,” Sanders said of raising the standard for published studies. He suggested that having two peer-reviewed journal articles would be a better standard. He also noted that there have been prominent retractions of erroneous studies that were published in only one journal, such as a fraudulent 1998 Lancet article that suggested a link between a vaccine and autism.
Conaway said the bill would put doctors in a better position to prescribe the medications that they feel will be best for their patients, without concerns about malpractice lawsuits.
The bill was opposed by Express Scripts Inc., which provides prescription-drug benefits under the state plan.
The bill received bipartisan support in the Assembly Heath and Senior Services Committee, where it was released by an 11-0 vote, with Assemblyman Erik Peterson (R-Hunterdon, Somerset and Warren) abstaining. A Senate version of the bill hasn’t been introduced.